Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Inclusion Criteria:

• Patients with diabetic peripheral neuropathic pain
• Chronic daily pain present for at least 2 months
• On stable analgesic regimen for one month
• Baseline pain score greater than 40mm on a visual analog scale

Exclusion Criteria:

• Hypersensitivity to compounds in study drug or similar drugs
• Pregnant or lactating females
• Drug or alcohol abuse
• Unstable medical condition